Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer

2023-137

The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.

2024-01-30

2026-01-01

2027-01-01

Recruiting

Early phase I

12

Inclusion Criteria: 1. Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer 2. Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter 3. ECOG performance status: 0-2 4. Able to read and sign consent form in English and provide informed consent Exclusion Criteria: 1. Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT \> 2 times the upper limit of normal ALT/SGPT \> 2 times the upper limit of normal Total bilirubin \> 2 times the upper limit of normal Creatinine \> 2 times the upper limit of normal Hemoglobin \< 8gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 70,000/mm3 Absolute neutrophil cell count \< 2,000 per mm3 2. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits 3. Pregnant women 4. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be \>30 days prior to the first treatment visit 5. Investigational drug use within 30 days prior to first treatment dose 6. History of systemic autoimmune disease 7. Patient with known hypersensitivity to tocilizumab 8. Active infection 9. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-03-28